Product manufacturing, especially pharmaceutical drug manufacturing necessarily entails some amount of risk. That is to say that in many manufacturing procedures that may be used in making products, there always exists some probability that an issue may occur. In some instances, deviations in an established manufacturing procedure may lead to unrecoverable product losses, and thus, unrecoverable profit loss. Even worse, if undetected, a deviation in the manufacturing process of a product has potential to cause injury to an end consumer of the product.
It is therefore important for manufacturing facility stakeholders to be able to understand what aspects of their manufacturing facility's operations contribute to risk so that corrective action can be taken to avoid or mitigate such risk in the future. However, achieving a common and accurate understanding of the risk is difficult because individual stakeholders may recognize different risk factors, and may attribute different severities to each factor. Further, heuristic methods used in traditional industry practice, which are devoid of data-driven metrics and analysis, often fail to identify correct risk factors and further fail to accurately determine a probability that such factors will actually lead to an issue occurring.